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Interpersonal Relationships Intervention and Cardiovascular Health

An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03670368
Enrollment
416
Registered
2018-09-13
Start date
2018-08-27
Completion date
2025-08-21
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Health

Brief summary

The purpose of this study is to determine whether random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.

Detailed description

Participants will be undergraduate students randomly assigned to either being in the mentor or comparison group. A second set of participants will be randomly assigned to either being in the mentee or comparison group. These participants will come from Chicago Public School elementary schools. In total, there will be 125 mentors, 125 comparators, 125 mentees, and 125 comparators. Participants will come for a laboratory visit in which cardiovascular health measures will be taken (details below). Visits will occur once at baseline (before the intervention starts), and once post-intervention. There will be a mid-point assessment of questionnaires. Participants in the intervention group will engage in one-on-one mentoring sessions (mentors together with mentees) once a week after school for the school year. Participants in the comparator group will receive written versions of all materials covered in the mentoring sessions.

Interventions

BEHAVIORALMentoring

The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.

BEHAVIORALComparison group - written materials

Written materials from the mentoring sessions will be provided to those in the comparison group

Sponsors

Northwestern University
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
DePaul University
CollaboratorOTHER
University of Illinois at Chicago
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* undergraduate students for mentors * Chicago Public School students for mentees

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Metabolic symptomsChange in metabolic symptoms from baseline to approximately 1 year laterMetabolic symptoms per International Diabetes Federation guidelines
Flow-mediated vasodilationChange in flow-mediated vasodilation from baseline to approximately 1 year laterBrachial artery diameter change
HOMA-IRChange in HOMA-IR score from baseline to approximately 1 year laterHomeostatic Model Assessment of Insulin Resistance

Secondary

MeasureTime frameDescription
Pro-inflammatory cytokinesChange from baseline to approximately 1 year laterStandardized and averaged values of pro-inflammatory cytokines + CRP
Stimulated cytokine productionChange from baseline to approximately 1 year laterStandardized and averaged values of stimulated pro-inflammatory cytokines
Glucocorticoid sensitivityChange from baseline to approximately 1 year laterStandardized and averaged values of cytokine production after stimulation plus addition of cortisol

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026